Patients on non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2-selective NSAIDs, have reduced risk of gastric ulcers by taking NEXIUM® (esomeprazole magnesium). These results were from from two clinical trials and will be in the April 2006 edition of the American Journal of Gastroenterology.
NSAIDs include traditional, non-selective drugs, such as ibuprofen, naproxen and aspirin, and newer COX-2-selective agents.
The study which was a double-blind, randomized, six-month trial collected data and showed that significantly fewer patients taking either NEXIUM 20 mg or NEXIUM 40 mg, in addition to their regular non-selective NSAID/COX-2-selective therapy, developed an ulcer at six months, compared to those taking a placebo (5.2 percent and 4.6 percent, respectively, vs. 17 percent, p<0.001).
Data from the two studies which were double-blind, randomized, placebo-controlled trials involved a total of 844 (U.S.) and 585 (multinational) patients. They were randomly assigned in a 1:1:1 ratio to treatment with either NEXIUM 20 mg, NEXIUM 40 mg or a placebo. Patients were continuous NSAID users (i.e., receiving daily non-selective NSAID or COX-2 therapy for at least four weeks before and throughout the duration of the six-month trial) at risk of developing a gastric or duodenal ulcer as a result of older age (>60 years) and/or a history of previous gastric ulcers.
The results were noted and analyzed for the study.